Vascular risk screening and management after late-onset seizures

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

This project will test whether screening and treating blood pressure, cholesterol, BMI and other vascular risks in people who have their first unprovoked seizure after age 50 can lower their future risk of stroke and heart disease.

Quick facts

• Study type: Observational
• Enrollment: 420 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Sahlgrenska University Hospital (other)
• Locations: 3 sites (Borås and 2 other locations)
• Trial ID: NCT07116330 on ClinicalTrials.gov

What this trial studies

The project uses a cluster design in which participating clinics adopt routine vascular risk factor screening (blood pressure, medical history, BMI, and laboratory tests) for patients with new-onset unprovoked seizures after age 50. It has two linked components: a prospective single-group observational cohort where screened patients are followed for one year to document risk-factor management and short-term outcomes, and a register-based cohort comparing all patients at participating sites to historical controls with at least 5 (likely 10) years of follow-up. The register study will use time-to-event analyses (Kaplan–Meier) to detect differences in long-term cardiovascular events at the system level. The combined approach aims to show whether implementing routine vascular risk assessment in this population changes patient care and long-term cardiovascular morbidity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50 or older presenting with a first unprovoked seizure or new-onset epilepsy at a participating clinic who can give informed consent and do not have progressive brain disease.

Not a fit: Patients with prior diagnosed seizures or epilepsy, prior stroke or TIA, progressive brain disease, or those unable to consent are unlikely to benefit from this specific intervention or may be excluded.

Why it matters

Potential benefit: If successful, routine vascular risk screening after late-onset seizures could lead to earlier prevention and fewer strokes and cardiovascular events in this patient group.

How similar studies have performed: Vascular risk screening and management has reduced cardiovascular events in other high-risk populations, but applying this approach specifically to people with late-onset seizures is novel and not yet proven in large studies.

Eligibility criteria

Inclusion Criteria

Clinical study:

\- First assessment for unprovoked seizures or epilepsy with onset after age 50 -- - vascular risk factor evaluation per the new routine at participating care givers

Register study:

* age ≥50 with a first-ever outpatient appointment to one of the participating clinics and
* a first-listed diagnostic code for seizures or epilepsy (ICD-10: R568, G40)

Exclusion Criteria

Clinical study:

* Inability to consent.
* Progressive brain disease (tumour or degenerative)

Register study:

* preexisting seizures/epilepsy, as demonstrated by a registered diagnostic code for seizures (ICD-10: R568, G40, G41) or a dispensed antiseizure medication (ATC-code: N03) more than 3 months before the initial consultation
* a registered diagnostic code for stroke or TIA (ICD-10: I61, I63, I64, or G45 except G454) before the initial consultation, or
* progressive brain disease, as indicated by diagnostic codes or drug prescriptions suggestive of brain tumors (ICD-10: C71, D33, D43, C793) or
* neurocognitive disorders (ICD-10: F00-F03, F051, G30, G318, G912; ATC code: N06D).

Where this trial is running

Borås and 2 other locations

• Södra Älvsborg Sjukhus — Borås, Sweden (RECRUITING)
• Salgrenska University Hospital — Gothenburg, Sweden (RECRUITING)
• Skånes universitetssjukhus — Malmö, Sweden (RECRUITING)

Study contacts

• Study coordinator: Johan Zelano, MD PhD

Conditions: Epilepsy, Seizure, vascular risk, cardiovascular